Fresh Competition Coming For Narcan In US
Amphastar Receives Approval For 505(b)(2) Naloxone As Amneal Files Generic
Further US hybrid and generic rivals to Narcan are in the works, with Amphastar having just received an FDA nod for its naloxone nasal spray in a proprietary device as Amneal files an ANDA for a further generic version.
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With a continuing focus on complex generics, Amneal has revealed a trio of US filings targeting ProAir, Lumigan and Diprivan.
Padagis has set out two first-to-file ANDA submissions in the US, challenging Hikma’s Kloxxado as well as Evofem’s Phexxi. The former Perrigo Rx business has also just launched two limited-competition generics.
Amphastar has delivered another successful quarter, bolstered by sales of glucagon and epinephrine, as it prepares to roll out a number of commercially attractive products and complete a significant branded product acquisition.